a study to investigate biomarkers after single doses of anticoagulants in healthy young male and healthy elderly participants (mk-0000-216 am1)

Conditions: Thrombosis

Summary: this is a study to investigate biomarkers after single oral doses of the anticoagulant agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly subjects.


Eligibility criteria:
inclusion criteria for non-hemophilia participants: panel a - male or female between 65 to 85 years of age panel b - male between 18 to 45 years of age both panels * weight of ≥50 kg and ≤110 kg * in good health * no clinically significant abnormality on electrocardiogram (ecg) * nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months exclusion criteria for non-hemophilia participants: * history of stroke, chronic seizures, or major neurological disorder * history of clinically significant endocrine, gastrointestinal (including peptic ulcer disease), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * history of malignant neoplastic disease, with the exception of adequately treated non-melanomatous skin carcinoma or other malignancies that have been successfully treated ≥10 years prior to the study * history of a thrombotic or platelet-related disorder including prior deep venous thrombosis or pulmonary embolus * use of warfarin, coumadin, heparin, aspirin, dabigatran etexilate, rivaroxaban or dipyridamole within 2 weeks * history of poor wound healing * unable to refrain from or anticipates the use of any medication, including aspirin and aspirin-containing products, all non-steroidal anti-inflammatory drug (nsaid)-containing products (including pain, cold and allergy products, etc.) and including prescription and non-prescription drugs or herbal remedies (such as st. john's wort \[hypericum perforatum\]) beginning approximately 2 weeks (or 5 half-lives) prior to initiation of the treatment periods, throughout the study until the post-study visit * consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml/10 ounces\], wine \[125 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) per day * consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day * major surgery, donation or loss of 1 unit of blood (approximately 500 ml) or participation in another investigational study within 4 weeks * history of significant multiple and/or severe allergies (including latex allergy), or an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food, including dabigatran etexilate and rivaroxaban * current regular user (including illicit drugs or has a history of drug \[including alcohol\] abuse within approximately 6 months * history (including family history if hereditary) or symptoms of clinically relevant bleeding disorder * organic lesion at risk of bleeding (e.g., aneurysm, cavernous hemangioma, arterio-venous malformation) * history of frequent epistaxis or has recurrent or active gingivitis or hemorrhoids inclusion criteria for hemophilia participants: * male with diagnosis of hemophilia b between 18 to 64 years of age * weight of ≥110 lbs and ≤300 lbs * has not received clotting factor in the 7 days prior to blood sampling * no active bleeding event * no procedure or surgery in the past 8 weeks * judged to be in good health based on medical history * has not smoked more than 2 cigarettes per day for at least approximately 1 week prior; has not smoked a pipe or cigar or chewed tobacco for at least 3 days prior * can refrain from the use of all nsaids (e.g., advil, aleve, aspirin), all nsaid-containing products (including pain, cold, and allergy products, etc.), herbal meds or drugs for 7 days prior to the date of study procedure exclusion criteria for hemophilia participants: * clinically significant endocrine, gastrointestinal (including peptic ulcer disease), cardiovascular, hematological (except factor ix deficiency), immunological, renal, respiratory, neurological or genitourinary abnormalities or diseases * history of malignant neoplastic disease, with the exception of adequately treated non-melanomatous skin carcinoma or other malignancies that have been successfully treated ≥10 years prior to the study * consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml/10 ounces\], wine \[125 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) within 24 hours prior to study procedures * major surgery, donation or loss of 1 unit of blood (approximately 500 ml) or participation in another investigational study within 7 days prior to the date of study procedures * current regular user (including illicit drugs or has a history of drug \[including alcohol\] abuse within approximately 6 months

Keywords: hemophilia b